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Akeso Announces Completion of Patient Enrollment in Phase III Clinical Trial for Ivonescimab as First-Line Treatment for Biliary Tract Cancer Compared to PD-L1 Therapy
Akeso (9926.HK) has recently announced the completion of patient enrollment in its Phase III, multicenter, randomized, controlled, registrational study evaluating ivonescimab, in combination with standard therapy, against durvalumab (PD-L1) combination therapy, for the first-line treatment of advanced biliary tract cancer (BTC) (AK112-309/HARMONi-GI1). This Phase III trial is being conducted in China.
About this update from Akeso, Inc.
[{"type":"text","content":"HONG KONG, Sept. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) has recently announced the completion of patient enrollment in its Phase III, multicenter, randomized, controlled, registrational study evaluating ivonescimab, in combination with standard therapy, against durvalumab (PD-L1) combination therapy, for the first-line treatment of advanced biliary tract cancer (BTC) (AK112-309/HARMONi-GI1). This Phase III trial is being conducted in China.","length":445,"tagName":"p"},{"type":"text","content":"Ivonescimab has previously shown significant positive results in the randomized, double-blind, controlled Phase III study (HARMONi-2), where it was compared head-to-head with pembrolizumab. These results led to its approval as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC), marking its second approved indication. In addition, the Phase III trial of ivonescimab in combination with chemotherapy compared to tislelizumab combined with chemotherapy as a first-line treatment for squamous NSCLC, also delivered significant positive outcomes. These results highlight ivonescimab's strong clinical breakthroughs. Whether compared to PD-1 monotherapy, PD-1 plus chemotherapy (current standard therapies for various cancers), or VEGF-related treatments, ivonescimab has consistently demonstrated its ability to drive clinical innovation.","length":865,"tagName":"p"},{"type":"text","content":"Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings:","length":171,"tagName":"p"},{"type":"text","content":"Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints):","length":102,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial)","length":100,"tagName":"p"}]},{"val":[{"type":"text","content":"First-line squamous NSCLC (versus tislelizumab + chemotherapy)","length":67,"tagName":"p"}]},{"val":[{"type":"text","content":"NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies)","length":75,"tagName":"p"}]},{"val":[{"type":"text","content":"First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy)","length":71,"tagName...